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U.S. Department of Health and Human Services

Import Refusal Report
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Refusal Details as Recorded in OASIS by FDA

for Refusal 144-4152610-2/1/5

Manufacturer FEI1000356953
Manufacturer NameShanghai Long Distance Telecommunication Import Office  
Manufacturer Address line 1Telecommunication Import Office  
Manufacturer Address line 2  
Manufacturer's CityShanghai  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code76NRD  
Importer's Product DescriptionVACUUM FORMING MACHINE  
Refusal Date12-Aug-2010  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 144-4152610-2/1/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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